Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-03-19 @ 5:08 PM
Study NCT ID:
NCT04179461
Status:
COMPLETED
Last Update Posted:
2021-08-20
First Post:
2019-11-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Personalized Treatment Algorithms for Difficult-to-treat Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D006633', 'term': 'Histamine Antagonists'}, {'id': 'D017332', 'term': 'Cetirizine'}, {'id': 'D017336', 'term': 'Loratadine'}, {'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000068656', 'term': 'Mometasone Furoate'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}, {'id': 'D001507', 'term': 'Beclomethasone'}, {'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D018494', 'term': 'Histamine Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D006919', 'term': 'Hydroxyzine'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003533', 'term': 'Cyproheptadine'}, {'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D013258', 'term': 'Steroids, Chlorinated'}, {'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Theresa.Guilbert@cchmc.org', 'phone': '(513) 636-6771', 'title': 'Theresa Guilbert, MD, MS', 'organization': "Cincinnati Children's Hospital Medical Center"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Review for possible adverse events was completed at study visits and follow-up phone calls by the research coordinator. If adverse events were identified, they were documented on the Adverse Event Reporting Form and reviewed at the meeting of the Steering committee.', 'eventGroups': [{'id': 'EG000', 'title': 'Personalized Treatment', 'description': "Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment.\n\nStudy participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.\n\nCholecalciferol: Oral administration\n\nantihistamine: Oral administration\n\nAzithromycin: Oral administration\n\nemollient cream: Topical\n\nFluticasone Propionate: Nasal spray\n\nAsthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.", 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 12, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Asthma Exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Streptococcal Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Major Depressive Disorder', 'notes': 'Major depressive disorder requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric Evaluation', 'notes': 'Psychiatric Evaluation requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Composite Asthma Severity Index (CASI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Personalized Treatment', 'description': "Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment.\n\nStudy participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.\n\nCholecalciferol: Oral administration\n\nantihistamine: Oral administration\n\nAzithromycin: Oral administration\n\nemollient cream: Topical\n\nFluticasone Propionate: Nasal spray\n\nAsthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan."}], 'classes': [{'title': 'V1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '6'}]}]}, {'title': 'V2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}]}]}, {'title': 'V3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000'], 'pValueComment': 'Change in CASI score from V1 to V3', 'groupDescription': 'The modified CASI score incorporates key asthma outcomes such as symptoms, healthcare utilization, and medication dose.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the CASI was captured at clinical visits. 3. A level of statistical significance was established at \\< 0.05.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12 months', 'description': 'CASI was measured by questionnaire and is a severity score of symptom burden, exacerbations, healthcare utilization, lung function and dose of inhaled corticosteroids. The change in CASI score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).\n\n\\[The CASI score has a minimum value = 0, maximum value = 20, a higher score indicates greater asthma severity\\]', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '17 participants whom had complete data sets were analyzed. 4 participants withdrew early from the study and were not included in this analysis due to incomplete data.'}, {'type': 'SECONDARY', 'title': 'Asthma Control Test (ACT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Personalized Treatment', 'description': "Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment.\n\nStudy participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.\n\nCholecalciferol: Oral administration\n\nantihistamine: Oral administration\n\nAzithromycin: Oral administration\n\nemollient cream: Topical\n\nFluticasone Propionate: Nasal spray\n\nAsthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan."}], 'classes': [{'title': 'V1', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '23.0'}]}]}, {'title': 'V2', 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '24.2'}]}]}, {'title': 'V3', 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '24.2'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000'], 'pValueComment': 'The change in ACT score from V1 to V2 (the period between V1 and V2).', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the c-ACT/ACT was captured at clinical visits and from monthly phone calls. Because c-ACT/ACT could vary through time, we calculated the average c-ACT/ACT between V1-V2 and V2-V3. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \\< 0.05.'}, {'pValue': '0.01', 'groupIds': ['OG000'], 'pValueComment': 'The change in ACT score from V1-V2 to V2-V3.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the c-ACT/ACT was captured at clinical visits and from monthly phone calls. Because c-ACT/ACT could vary through time, we calculated the average c-ACT/ACT between V1-V2 and V2-V3. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \\< 0.05.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12 months', 'description': 'ACT was measured by questionnaire, assessing frequency of reported asthma symptoms, rescue medication use, the effect of asthma on daily functioning, and overall asthma control. The change in ACT score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).\n\n\\[The ACT score has a minimum value = 5, maximum value = 25, a score 19 indicates well-controlled asthma\\]', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '17 participants whom had complete data sets were analyzed. 4 participants withdrew early from the study and were not included in this analysis due to incomplete data.'}, {'type': 'SECONDARY', 'title': 'Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Personalized Treatment', 'description': "Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment.\n\nStudy participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.\n\nCholecalciferol: Oral administration\n\nantihistamine: Oral administration\n\nAzithromycin: Oral administration\n\nemollient cream: Topical\n\nFluticasone Propionate: Nasal spray\n\nAsthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan."}], 'classes': [{'title': 'V1', 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '0.86'}]}]}, {'title': 'V2', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '0.85'}]}]}, {'title': 'V3', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '0.87'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000'], 'pValueComment': 'The Change in FEV1/FVC from Visit 1 to Visit 3', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': "The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data and the Bowker's test was used to compare categorical FEV1-FVC data. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \\< 0.05."}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12 months', 'description': 'FEV1 is air volume exhaled in 1 second during spirometry. Forced vital capacity is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. The change in FEV1/FVC was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months). This will be used as a measurement in asthma severity.\n\n\\[A lower FEV1/FVC ratio indicates more severe asthma\\]', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '17 participants whom had complete data sets were analyzed. 4 participants withdrew early from the study and were not included in this analysis due to incomplete data.'}, {'type': 'SECONDARY', 'title': 'Adherence of Asthma Controller Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Personalized Treatment', 'description': "Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment.\n\nStudy participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.\n\nCholecalciferol: Oral administration\n\nantihistamine: Oral administration\n\nAzithromycin: Oral administration\n\nemollient cream: Topical\n\nFluticasone Propionate: Nasal spray\n\nAsthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan."}], 'classes': [{'title': 'V1', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '57'}]}]}, {'title': 'V3', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '53'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000'], 'pValueComment': 'Change between baseline (V1) to end of study (V3)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Intervention adherence and end of study adherence were each calculated based on the 30 days prior to end of intervention and V3, respectively, in order to assess a consistent timeframe. The paired Wilcoxon signed rank test was conducted to compare controller inhaler adherence during baseline, adherence intervention, and end of study.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Adherence was measured using the Propeller Health Inhaler monitor and web-based software management platform that tracks adherence of asthma medications. The change in adherence was calculated between V1 (baseline) to V3 (12 Months).', 'unitOfMeasure': 'percentage of medication taken', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '16 participants whom had complete data sets were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Personalized Treatment', 'description': "Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment.\n\nStudy participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.\n\nCholecalciferol: Oral administration\n\nantihistamine: Oral administration\n\nAzithromycin: Oral administration\n\nemollient cream: Topical\n\nFluticasone Propionate: Nasal spray\n\nAsthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Personalized Treatment', 'description': "Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment.\n\nStudy participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.\n\nCholecalciferol: Oral administration\n\nantihistamine: Oral administration\n\nAzithromycin: Oral administration\n\nemollient cream: Topical\n\nFluticasone Propionate: Nasal spray\n\nAsthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'spread': '2.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Primary home within a 40 mile radius of Cincinnati Children's Base Location", 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Health insurance coverage at enrollment', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '1 participant withdrew from the study prior to being assigned a personalized treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-19', 'size': 416717, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-02T12:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "The study has 3 study phases: baseline, intervention, and observation. Each participant will independently transition through these study phases.\n\nBaseline period: Each participant will be given a treatment recommendation according to their asthma severity/control using the National Asthma Education and Prevention Program (NAEPP asthma guidelines).\n\nIntervention period: Each participant will be given a personalized treatment plan based on their asthma severity/control during the baseline period, biologic, and environmental factors.\n\nObservation period: All participants will be observed for at least 6 months. Investigators will track the participant's personal outcomes (comparing to baseline) for reutilization, symptom-free days, and quality of life."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2019-11-14', 'resultsFirstSubmitDate': '2021-06-10', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-28', 'studyFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Composite Asthma Severity Index (CASI)', 'timeFrame': 'Baseline to 12 months', 'description': 'CASI was measured by questionnaire and is a severity score of symptom burden, exacerbations, healthcare utilization, lung function and dose of inhaled corticosteroids. The change in CASI score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).\n\n\\[The CASI score has a minimum value = 0, maximum value = 20, a higher score indicates greater asthma severity\\]'}], 'secondaryOutcomes': [{'measure': 'Asthma Control Test (ACT)', 'timeFrame': 'Baseline to 12 months', 'description': 'ACT was measured by questionnaire, assessing frequency of reported asthma symptoms, rescue medication use, the effect of asthma on daily functioning, and overall asthma control. The change in ACT score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).\n\n\\[The ACT score has a minimum value = 5, maximum value = 25, a score 19 indicates well-controlled asthma\\]'}, {'measure': 'Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC)', 'timeFrame': 'Baseline to 12 months', 'description': 'FEV1 is air volume exhaled in 1 second during spirometry. Forced vital capacity is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. The change in FEV1/FVC was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months). This will be used as a measurement in asthma severity.\n\n\\[A lower FEV1/FVC ratio indicates more severe asthma\\]'}, {'measure': 'Adherence of Asthma Controller Medication', 'timeFrame': 'Baseline to 12 months', 'description': 'Adherence was measured using the Propeller Health Inhaler monitor and web-based software management platform that tracks adherence of asthma medications. The change in adherence was calculated between V1 (baseline) to V3 (12 Months).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma in Children']}, 'referencesModule': {'references': [{'pmid': '35123074', 'type': 'DERIVED', 'citation': 'Guilbert TW, Biagini JM, Ramsey RR, Keidel K, Curtsinger K, Kroner JW, Durrani SR, Stevens M, Pilipenko V, Martin LJ, Kercsmar CM, Hommel K, Hershey GKK. Treatment by biomarker-informed endotype vs guideline care in children with difficult-to-treat asthma. Ann Allergy Asthma Immunol. 2022 May;128(5):535-543.e6. doi: 10.1016/j.anai.2022.01.030. Epub 2022 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'Asthma is a common, complex and costly chronic condition. Moreover, asthma is heterogeneous in terms of treatment response. This heterogeneity contributes to the difficulty in both studying and treating asthma. This is a pilot study to improve health outcomes in youths with difficult to treat asthma with ongoing symptoms and healthcare utilization despite medium to high doses of inhaled corticosteroids. Asthma heterogeneity in both disease pathophysiology and treatment response contributes to the difficulty in both studying and managing asthma. In order to begin to develop personalized algorithms for patients, investigators need to model novel biomarkers and other factors that contribute to individual differences in asthma outcome and test other factors that contribute to individual differences in asthma outcome and test personalized treatment strategies.', 'detailedDescription': "With this study investigators will conduct study visits to determine and quantify known molecular, genetic, genomic, epigenetics, immunologic, and exposure biomarkers that will help elucidate molecular disease endotype within the difficult-to-treat phenotype. This information will be used along with clinical, psychosocial, and adherence data to develop a personalized treatment plan. Following the personalized treatment plan, study clinicians will prescribe the medications through a home delivery or routine pharmacy depending on the family's preference and covered by the participant's health insurance. Investigators will track disease outcome metrics including exacerbations, symptom-free days, and asthma symptom scores to determine the effectiveness of this personalized approach."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* History of provider-diagnosed asthma\n* Meets one of the following definition for NAEPP guidelines uncontrolled moderate persistent asthma or severe persistent asthma in the past 12 months:\n\n * NAEPP step 3-4 with one of the following criteria in the past 12 months:\n\n * Two Asthma Control Test (ACT) scores \\<20\n * 1 Urgent Care or Emergency Department visit or hospitalization for asthma\n * \\>2 prednisone bursts\n * NAEPP step 5-6\n* Current health insurance coverage at enrollment. This will be verified at V1 at the registration desk. If the family loses insurance during the study, the patient will be referred to the pulmonary social worker and financial office for assistance\n* Reside at a primary home on average 5 out of 7 days a week.\n* Primary home is within a 40 mile radius of Cincinnati Children's Base location or PI's discretion.\n\nExclusion Criteria:\n\n* Received biologic therapy 6 months prior to enrollment\n* Received systemic steroids 6 weeks prior to enrollment\n* Active chronic disease apart from asthma or allergic disease\n* Co-morbid lung disease\n* Dependence on immunosuppressive drugs for a condition other than asthma\n* Participant is pregnant\n* Has a severe bleeding disorder\n* Has significant developmental disability\n* Share a bedroom with a currently enrolled Breath Warriors study participant"}, 'identificationModule': {'nctId': 'NCT04179461', 'briefTitle': 'Personalized Treatment Algorithms for Difficult-to-treat Asthma', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Personalized Treatment Algorithms for Difficult-to-treat Asthma: Bench to Community', 'orgStudyIdInfo': {'id': 'ARC 7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personalized Treatment', 'description': "Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment.\n\nStudy participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.", 'interventionNames': ['Drug: Cholecalciferol', 'Drug: antihistamine', 'Drug: Azithromycin', 'Drug: emollient cream', 'Drug: Fluticasone Propionate', 'Drug: Asthma Controller Medication']}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DRUG', 'otherNames': ['Vitamin D'], 'description': 'Oral administration', 'armGroupLabels': ['Personalized Treatment']}, {'name': 'antihistamine', 'type': 'DRUG', 'otherNames': ['cetirizine', 'loratadine'], 'description': 'Oral administration', 'armGroupLabels': ['Personalized Treatment']}, {'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['Zithromax'], 'description': 'Oral administration', 'armGroupLabels': ['Personalized Treatment']}, {'name': 'emollient cream', 'type': 'DRUG', 'description': 'Topical', 'armGroupLabels': ['Personalized Treatment']}, {'name': 'Fluticasone Propionate', 'type': 'DRUG', 'otherNames': ['Flonase Nasal Spray'], 'description': 'Nasal spray', 'armGroupLabels': ['Personalized Treatment']}, {'name': 'Asthma Controller Medication', 'type': 'DRUG', 'otherNames': ['Mometasone/Formoterol', 'Fluticasone/Salmeterol', 'Mometasone Furoate', 'Fluticasone', 'Beclomethasone', 'Budesonide/Formoterol', 'Tiotropium'], 'description': 'Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.', 'armGroupLabels': ['Personalized Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Theresa Guilbert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}, {'name': 'Gurjit K Khurana Hershey, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Theresa Guilbert, MD', 'investigatorAffiliation': "Children's Hospital Medical Center, Cincinnati"}}}}